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Indications - Amlexanox is indicated for the treatment of aphthous ulcers in people with normal immune system.

Dosage & Administration - Adults (over 18 years of age): Apply the paste as soon as possible after noticing the symptoms of an aphthous ulcer. Continue to use the paste four times daily, preferably following oral hygiene after breakfast, lunch, dinner, and at bedtime. Dry the ulcer(s) by gently patting it with a soft, clean cloth. Wash hands before applying. Moisten the tip of the index finger & squeeze a dab of paste approximately ¼ inch (0.5 cm) on to the finger tip. Gently dab the paste on to each ulcer. Repeat the process if more than one ulcer are present. Wash hands after application. Use the paste until the ulcer heals. If significant healing or pain relief has not occurred in 10 days, consultation with the physician is required.

Side Effects - The most common side effects are transient pain, stinging and/or burning at the site of application. The less frequent side effects are contact mucositis, nausea, and diarrhea.

Contraindications - Amlexanox oral paste is contraindicated in patients with known hypersensitivity to Amlexanox or other ingredients in the formulation.

Others - Pregnancy & Lactation Pregnancy category B. No adverse fetal effects were observed during teratological studies on animals, but there are no adequate and well-controlled studies in pregnant women. So this drug should be used during pregnancy only if clearly needed. Lactation: Amlexanox was found in the milk of lactating rats; therefore, caution should be exercised when administering Amlexanox oral paste to a nursing woman.